510(k) K113634 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Feb 14, 2012 |
| Received | Dec 9, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113634
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.